Clinical Trials for Head And Neck Cancer

A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable advanced solid tumors, ECOG 0–1, and limited treatment options receive oral VLS-1488 monotherapy; eligible cancers include high-grade serous ovarian, squamous non-small cell lung, triple-negative breast, and selected gastrointestinal, head and neck, and gynecologic tumors. VLS-1488 inhibits KIF18A, a mitotic kinesin involved in chromosome alignment.

ClinicalTrials.gov ID: NCT05902988

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously treated, locally advanced unresectable or metastatic melanoma, head and neck squamous cell carcinoma, non-small-cell lung cancer, triple-negative breast cancer, or classical Hodgkin lymphoma receive intravenous CTX-8371 monotherapy every 2 weeks. CTX-8371 is a bispecific antibody targeting PD-1 and PD-L1; most solid-tumor cohorts require progression after prior PD-1/PD-L1 therapy.

ClinicalTrials.gov ID: NCT06150664

Phase I/II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced or unresectable melanoma, small-cell or non-small-cell lung cancer, or head and neck squamous cell carcinoma whose most recent anti-PD-(L)1–containing regimen failed to produce a response or was followed by relapse within 12 months receive carboplatin–paclitaxel plus autologous RAPA-201 cells. RAPA-201 is a rapamycin-resistant, Th1/Tc1-polarized CD4+/CD8+ T-cell product without a single tumor-antigen target; the expanded cohort also receives pembrolizumab maintenance.

ClinicalTrials.gov ID: NCT05144698

A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously treated, unresectable locally advanced or metastatic Nectin-4–expressing solid tumors, measurable disease, and no remaining therapy with demonstrated benefit receive IPH4502 monotherapy. IPH4502 is an investigational Nectin-4–targeted antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT06781983

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: For adults with progressing, unresectable or recurrent advanced solid tumors or lymphomas who have no remaining standard treatment options and at least one injectable, measurable lesion, this study evaluates intratumoral ONM-501 alone or with cemiplimab. ONM-501 is an investigational STING-directed immunotherapy designed to enhance intracellular cGAMP delivery and sustain STING activation; cemiplimab inhibits PD-1.

ClinicalTrials.gov ID: NCT06022029

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously treated or treatment-refractory unresectable locally advanced or metastatic solid tumors harboring HER2 expression, amplification, or an activating mutation receive intravenous BL-M07D1 every 21 days. BL-M07D1 is a HER2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor to HER2-expressing cells.

ClinicalTrials.gov ID: NCT06293898

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with ECOG 0–1 and selected advanced or metastatic solid tumors receive AZD6750, an investigational CD8-guided IL-2 agent designed to preferentially stimulate CD8-positive T cells. A separate cohort of patients with stage IV NSCLC receives AZD6750 plus rilvegostomig, an investigational PD-1/TIGIT bispecific antibody.

ClinicalTrials.gov ID: NCT07115043

Phase I Trial of [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with progressive, metastatic or inoperable gastrointestinal neuroendocrine tumors, pheochromocytoma/paraganglioma, small cell lung cancer, primary kidney cancer, or selected head and neck cancers are eligible if at least half of their measurable tumor shows somatostatin-receptor uptake on PET. Patients receive intravenous [212Pb]VMT-alpha-NET, a somatostatin-receptor–targeted radioligand that delivers alpha-particle radiation, every 8 weeks for four doses; a subset also receives [203Pb]VMT-alpha-NET for dosimetry.

ClinicalTrials.gov ID: NCT06479811

A Phase 1/2 Immunotherapy Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab in Patients with Advanced Solid Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Patients with locally advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, or HPV-negative head and neck squamous cell carcinoma who have no beneficial standard treatment option receive evofosfamide plus zalifrelimab and balstilimab. Evofosfamide releases a DNA-crosslinking agent in hypoxic tumor tissue; zalifrelimab blocks CTLA-4 and balstilimab blocks PD-1.

ClinicalTrials.gov ID: NCT06782555

A Phase 1/2 Open-Label, Umbrella Platform Design Study of MK-2870 With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously untreated, locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma without known HER2 positivity receive pembrolizumab plus fluoropyrimidine chemotherapy with or without sacituzumab tirumotecan. Sacituzumab tirumotecan is an investigational TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06469944